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In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60. |
|
| Dexmedetomidine-remifentanil(DEX-R) group | Experimental | General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg loading, and 1 mcg/kg/hr continuous infusion) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | administration of dexmedetomidine 1 mcg/kg/hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5 | categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline | When the patient's age is 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Leiter International Performance Scale at age of 30 months | Korean version of the Leiter International Performance Scale-Revised (Leiter-R), categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline | When the patient's age is 30 months old after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji-Hyun Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Other | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40923823 | Derived | Ji SH, Kang P, Cho SA, Park JB, Jang YE, Kim EH, Kim JT, Kim HS, Jung HJ, Jung HA, Lee HC, Lee JH. Effects of Dexmedetomidine-Remifentanil on Neurodevelopment of Children after Inhalation Anesthesia: A Randomized Clinical Trial. Anesthesiology. 2025 Oct 1;143(4):827-834. doi: 10.1097/ALN.0000000000005634. Epub 2025 Sep 9. |
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| remifentanil | Drug | administration of remifentanil 0.1-0.2 mcg/kg/min |
|
| Sevoflurane | Drug | Anesthesia is maintained using sevoflurane. |
|
| Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7 |
categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline |
| When the patient's age is 7 years old after surgery |
| Child Behavior Checklist results | Child Behavior Checklist results at age of 30 months, 5 years and 7 years | When the patient's age become 30 months, 5 years and 7 years old after surgery |
| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077208 | Remifentanil |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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